Diagnostic Accuracy and Operational Efficiency of Point-of-Care Ultrasound (POCUS) in Long Bone Fractures: A Brazilian Multicenter Study

NCT07728227 | Not Yet Recruiting

• 2 other identifiers: 8.574.218Universal Trial Number (UTN)
• Study Type: observational
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the diagnostic accuracy and operational efficiency of Point-of-Care Ultrasound (POCUS) for identifying long bone fractures in the emergency department. Traditionally, suspected long bone fractures are diagnosed using X-rays. While effective, X-rays require transporting patients to a radiology suite, involve exposure to ionizing radiation, and can contribute to longer emergency room wait times. POCUS is a portable, radiation-free imaging tool that physicians perform directly at the patient's bedside. The investigators hypothesize that POCUS can accurately identify or rule out long bone fractures when compared to standard X-rays, and that its use will reduce the time required to make clinical decisions. This is a multicenter, prospective observational study. Participants arriving at the emergency department with a suspected long bone fracture will undergo a bedside ultrasound examination performed by a trained emergency physician. Following the ultrasound, all participants will receive standard-of-care X-ray imaging. Researchers will compare the initial POCUS findings to the final X-ray results (the reference standard) to determine the sensitivity and specificity of the ultrasound. Additionally, the study will measure operational timelines-including time to diagnosis, time to treatment decision, and total length of stay in the emergency department-to assess the impact of POCUS on hospital workflow and patient care efficiency.

Conditions

Bone Fractures; Long Bone Fracture

Keywords

POCUS; Ultrassound; Fractures; Bones; POCUS BONES BR

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures

  Sensitivity is the percentage of participants with a long bone fracture confirmed by the reference standard (conventional radiography independently interpreted by a blinded radiologist) who were correctly classified as having a fracture by point-of-care ultrasound (POCUS) performed by a trained emergency physician. Sensitivity is calculated as the number of true positive POCUS examinations divided by the total number of participants with a fracture on the reference standard, multiplied by 100. Reported as a percentage with a 95 percent confidence interval.

  From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours.

Secondary Outcomes (7)

• Positive Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures

  From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours

• Negative Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures

  From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours

• Overall Diagnostic Accuracy of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures

  From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours

• Interobserver Agreement Between Point-of-Care Ultrasound (POCUS) Operators

  From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours

• Time From Emergency Department Arrival to Point-of-Care Ultrasound (POCUS) Result

  From emergency department arrival to establishment of the fracture diagnosis, assessed up to 24 hours

Study Arms (2)

Arm A

POCUS performed before radiography

Arm B

Radiography performed before POCUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (18 years of age or older) presenting to the emergency departments of two major Brazilian academic hospitals: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) and Hospital das Clínicas da Faculdade de Medicina de Marília (HCFAMEMA). Eligible participants are those seeking care for acute extremity trauma with clinical suspicion of a long bone fracture, characterized by signs such as localized pain, visible deformity, swelling, or functional limitation. Patients presenting with open fractures, hemodynamic instability requiring immediate resuscitation, known previous fractures in the same anatomical segment, or those requiring immediate surgical intervention are excluded from this study population.

You may qualify if:

• Patients aged 18 years or older;
• Presenting with clinical suspicion of a long bone fracture (pain, deformity, swelling, or functional limitation);
• Provision of informed consent (signed Informed Consent Form - ICF).

You may not qualify if:

• Patients with open fractures;
• Hemodynamic instability (resuscitation priority);
• Known previous fractures in the same bone segment;
• Need for immediate surgical intervention;
• Refusal to participate.

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (9)

• Ribeiro MCF, Ribeiro MEF, Da Silva Dos Santos G, De Santos Lima AK, Leonel BMC, De Castro Trindade MMM, et al. Perfil epidemiológico das internações por fratura de fêmur no Brasil entre 2019 a 2023. Brazilian Journal of Implantology and Health Sciences [Internet]. 2024 Jun 17;6(6):1154¿64. Available from: https://bjihs.emnuvens.com.br/bjihs/article/view/2331

  BACKGROUND

• GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.

  PMID: 34723233 BACKGROUND

• Delniotis I, Bontinis V, Ktenidis K, Drakonaki EE, Galanis N. Diagnostic accuracy of ultrasound versus X-ray for distal forearm fractures in children and adolescents: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2024 Dec;50(6):2649-2662. doi: 10.1007/s00068-024-02451-9. Epub 2024 Feb 1.

  PMID: 38300283 BACKGROUND

• Matschiner E, Serban O, Fodor D, Blaivas M, Horn R, Koch J, Jakobi ML, Grevelding L, Osterwalder J, Srivastava D, Dietrich CF. Ultrasound in bone fracture diagnosis - a comparative meta-analysis and systematic review. Med Ultrason. 2025 Mar 2;27(1):52-62. doi: 10.11152/mu-4407. Epub 2024 Jun 28.

  PMID: 39078997 BACKGROUND

• Douma-den Hamer D, Blanker MH, Edens MA, Buijteweg LN, Boomsma MF, van Helden SH, Mauritz GJ. Ultrasound for Distal Forearm Fracture: A Systematic Review and Diagnostic Meta-Analysis. PLoS One. 2016 May 19;11(5):e0155659. doi: 10.1371/journal.pone.0155659. eCollection 2016.

  PMID: 27196439 BACKGROUND

• Osterwalder J, Hoffmann B, Blaivas M, Horn R, Matchiner E, Dietrich CF. A Plea for a Paradigm Shift from X-Ray to Ultrasound in Adults: An Update for Emergency Physicians, General Practitioners, Orthopedists and Sports Medicine Physicians. Diagnostics (Basel). 2025 Jul 21;15(14):1827. doi: 10.3390/diagnostics15141827.

  PMID: 40722577 BACKGROUND

• Smith KM, Zimmerman E, Trotter Z, Wai S. Diagnostic Accuracy of Point-of-Care Ultrasound for Acute Pediatric Ankle Injuries. Pediatr Emerg Care. 2025 Oct 1;41(10):e140-e145. doi: 10.1097/PEC.0000000000003439. Epub 2025 Jul 9.

  PMID: 40629668 BACKGROUND

• Delniotis I, Bontinis V, Delniotis A, Bontinis A, Drakonaki EE, Ktenidis K, Galanis N. Point-of-Care Ultrasound Versus X-ray for Pediatric Upper Extremity Injuries: A Safe and Radiation-Free Alternative? Pediatr Emerg Care. 2025 Oct 1;41(10):e156-e162. doi: 10.1097/PEC.0000000000003446. Epub 2025 Jul 11.

  PMID: 40643022 BACKGROUND

• Endara-Mina J, Kumar H, Ghosh B, Mehta A, Chandra Dey R, Singh P, Rai N, Mandadi M, Opara O, Quinonez J. Comparative use of ultrasound and radiography for the detection of fractures: a systematic review and narrative synthesis. Ann Med Surg (Lond). 2023 Sep 5;85(10):5085-5095. doi: 10.1097/MS9.0000000000001229. eCollection 2023 Oct.

  PMID: 37811018 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Emanuel A Balanga, Medical Doctor

CONTACT

+55 11 965011440; eabalanga@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Resident

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share